FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE
K Number: K946005
·
Decision Sep 25, 1995
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
3
Review Days
290
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Basic Information
- Device Name
- ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE
- K Number
- K946005
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Astral, Ltd.
- Date Received
- December 9, 1994
- Decision Date
- September 25, 1995
- Product Code
- FMT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FMT | Warmer, Infant Radiant | FDA class 2 | General Hospital |
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